FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VersaTREK™
DI: 00848838091742
·
Model: VersaTREK™ Myco Streptomycin, 7120-30
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VersaTREK™
- Primary DI
- 00848838091742
- Version / Model
- VersaTREK™ Myco Streptomycin, 7120-30
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-16
- Public Version
- 2
- Public Version Date
- 2026-02-04
- Public Version Status
- Update
- Public Device Record Key
- 572f2fd4-83de-4d5d-851d-632585e28bb5
- Distribution End Date
- 2025-08-04
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDB | System, Blood Culturing | Microbiology | 866.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30658 | Multiple antimycobacterial minimum inhibitory concentration (MIC) IVD, kit | A collection of reagents or test strips and other associated materials, containing multiple antimicrobial agents at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antimicrobials against a specific Mycobacterium organism, isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848838091742 | GS1 |